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微粒子姜黄素对慢性肾脏病进展的影响:MPAC-CKD 随机临床试验。

The effect of micro-particle curcumin on chronic kidney disease progression: the MPAC-CKD randomized clinical trial.

机构信息

Division of Nephrology, Department of Medicine, Western University, London, ON, Canada.

London Health Sciences Centre, London, ON, Canada.

出版信息

Nephrol Dial Transplant. 2023 Sep 29;38(10):2192-2200. doi: 10.1093/ndt/gfad037.

Abstract

BACKGROUND

Curcumin is a commonly used herbal supplement with anti-inflammatory and anti-fibrotic properties. Animal studies and small human trials suggest that curcumin reduces albuminuria in patients with chronic kidney disease (CKD). Micro-particle curcumin is a new, more bioavailable formulation of curcumin.

METHODS

To determine whether micro-particle curcumin versus placebo slows the progression of albuminuric CKD we conducted a randomized, double-blind, placebo-controlled trial with 6-month follow-up. We included adults with albuminuria [a random urine albumin-to-creatinine ratio >30 mg/mmol (265 mg/g) or a 24-h urine collection with more than 300 mg of protein] and an estimated glomerular filtration rate (eGFR) between 15 and 60 mL/min/1.73 m2 within the 3 months before randomization. We randomly allocated participants 1:1 to receive micro-particle curcumin capsules (90 mg/day) or matching placebo for 6 months. After randomization, the co-primary outcomes were the changes in albuminuria and the eGFR.

RESULTS

We enrolled 533 participants, but 4/265 participants in the curcumin group and 15/268 in the placebo group withdrew consent or became ineligible. The 6-month change in albuminuria did not differ significantly between the curcumin and placebo groups [geometric mean ratio 0.94, 97.5% confidence interval (CI) 0.82 to 1.08, P = .32]. Similarly, the 6-month change in eGFR did not differ between groups (mean between-group difference -0.22 mL/min/1.73 m2, 97.5% CI -1.38 to 0.95, P = .68).

CONCLUSIONS

Ninety milligrams of micro-particle curcumin daily did not slow the progression of albuminuric CKD over 6 months.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02369549.

摘要

背景

姜黄素是一种常用的草药补充剂,具有抗炎和抗纤维化特性。动物研究和小型人体试验表明,姜黄素可减少慢性肾脏病(CKD)患者的白蛋白尿。微粒子姜黄素是姜黄素的一种新的、更具生物利用度的配方。

方法

为了确定微粒子姜黄素与安慰剂相比是否能减缓白蛋白尿性 CKD 的进展,我们进行了一项为期 6 个月、随访 6 个月的随机、双盲、安慰剂对照试验。我们纳入了在随机分组前 3 个月内有白蛋白尿[随机尿白蛋白/肌酐比值>30mg/mmol(265mg/g)或 24 小时尿蛋白>300mg]和估计肾小球滤过率(eGFR)在 15 至 60ml/min/1.73m2之间的成年人。我们将参与者随机以 1:1 的比例分配至接受微粒子姜黄素胶囊(90mg/天)或匹配安慰剂治疗 6 个月。随机分组后,主要共同结局是白蛋白尿和 eGFR 的变化。

结果

我们共纳入了 533 名参与者,但姜黄素组有 4/265 名参与者和安慰剂组有 15/268 名参与者撤回了同意或不符合入选标准。姜黄素组和安慰剂组的 6 个月白蛋白尿变化差异无统计学意义[几何均数比 0.94,97.5%置信区间(CI)0.82 至 1.08,P=0.32]。同样,两组间 6 个月 eGFR 变化也无差异(组间平均差异-0.22ml/min/1.73m2,97.5%CI-1.38 至 0.95,P=0.68)。

结论

每日 90 毫克微粒子姜黄素在 6 个月内未能减缓白蛋白尿性 CKD 的进展。

试验注册

ClinicalTrials.gov 标识符:NCT02369549。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/763b/10539205/6a0936d0120d/gfad037fig1g.jpg

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